Advaxis Provides Update on MAA Filing and ADXS-HOT Program
July 10 2018 - 8:00AM
Business Wire
Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology
company focused on the discovery, development and commercialization
of immunotherapy products, today announced a clinical update, as
follows:
- Plans to withdraw its Conditional
Marketing Authorization Application (MAA) in the European Union for
axalimogene filolisbac to treat metastatic cervical cancer in
patients who progress beyond first-line therapy
- Submission of an Investigational New
Drug (IND) application with the U.S. Food and Drug Administration
(FDA) to study its first ADXS-HOT drug candidate for the treatment
of non-small cell lung cancer (NSCLC)
- Selection of prostate cancer as the
second cancer type within its ADXS-HOT program to move towards the
clinic, with an IND filing anticipated within the next six
months
Advaxis’ regulatory action in Europe is based on European
Medicines Agency (EMA) feedback following its initial review
indicating the application will likely need additional data to
support a conditional approval. The February 2018 submission
included data from the Phase 2 GOG-0265 study in 50 patients, which
showed a 12-month overall survival rate (primary efficacy endpoint)
of 38% (n=19/50) in women with persistent, recurrent or metastatic
carcinoma of the cervix, representing a 55% improvement over a
model-predicted 12-month overall survival rate of 24.5%. As
more than half of the women treated in this study had received
multiple prior lines of therapy including with bevacizumab
treatment, the 38% 12-month overall survival rate was unprecedented
when compared against historical data.
The Company continues to believe that the results from the
GOG-0265 study are clinically meaningful and provide
proof-of-concept that axalimogene filolisbac demonstrated clinical
activity in metastatic cervical cancer. The withdrawal of this
application does not impact the ongoing clinical trials of
axalimogene filolisbac. As previously communicated, Advaxis is
actively seeking a partner to support the late-stage cervical
cancer program.
The Company also announced that it has submitted an IND with the
FDA to study its first product candidate from the ADXS-HOT program,
ADXS-503, for the treatment of NSCLC. Upon allowance of the IND for
ADXS-503, the Company plans to initiate an open-label, Phase 1/2
clinical trial. Further details of the study design will be
provided after the IND is allowed. Advaxis expects the first
patient will be dosed by the end of 2018. Additionally, Advaxis
anticipates submitting a second IND from the ADXS-HOT program
within the next six months, for its drug candidate referred to as
ADXS-504, for the treatment of prostate cancer.
“We are pleased to submit the ADXS-503 IND and look forward to
advancing our ADXS-HOT NSCLC drug candidate into the clinic. Our
ADXS-HOT program leverages both the benefits of our Lm technology
platform, which has shown clinical activity in earlier generation
drug candidates, and the use of neoantigen targets. We believe that
neoantigen-based treatments have the potential to transform cancer
care, and the ADXS-HOT program allows us to develop cancer-type
specific therapies across a broad range of tumor types,” said
Kenneth A. Berlin, President and Chief Executive Officer of
Advaxis. “With our announcement today of plans for a second IND
submission for an ADXS-HOT construct in prostate cancer, we feel
confident we can reach proof-of-concept for these off-the-shelf
therapeutics in a relatively rapid and cost-effective manner.”
Advaxis affirms plans to submit a total of four INDs for drug
candidates from its ADXS-HOT program by the end of calendar year
2019, resulting in Phase 1/2 studies evaluating safety, immune
responses and preliminary clinical activity of four different
constructs addressing four different tumor types. Beyond NSCLC and
prostate cancer, the next two ADXS-HOT product candidates will be
selected from breast, colorectal, bladder, ovarian and head and
neck cancers.
About ADXS-HOT
ADXS-HOT is a program that leverages the Company’s proprietary
Lm technology to target hotspot mutations that commonly occur in
specific cancer types. ADXS-HOT drug candidates are designed to
target acquired shared or “public” mutations in tumor driver genes
along with other cancer-testes and oncofetal tumor-associated
antigens that also commonly occur in specific cancer types.
Although ADXS-HOT drug candidates have not yet been tested in
patients, each product candidate has been designed to potentially
treat all patients with a specific cancer type, without the need
for pre-treatment biomarker testing, biopsy, DNA sequencing or
diagnostic testing.
About Advaxis, Inc.
Advaxis, Inc. is a late-stage biotechnology company focused on
the discovery, development and commercialization of
proprietary Lm-based antigen delivery products. These
immunotherapies are based on a platform technology that utilizes
live attenuated Listeria monocytogenes (Lm) bioengineered to
secrete antigen/adjuvant fusion proteins. These Lm-based
strains are believed to be a significant advancement in
immunotherapy as they integrate multiple functions into a single
immunotherapy and are designed to access and direct antigen
presenting cells to stimulate anti-tumor T cell immunity, activate
the immune system with the equivalent of multiple adjuvants, and
simultaneously reduce tumor protection in the tumor
microenvironment to enable the T cells to eliminate tumors. Advaxis
has four franchises in various stages of clinical and preclinical
development: HPV-associated cancers, neoantigen therapy, hotspot/
cancer antigens and prostate cancer.
To learn more about Advaxis, visit www.advaxis.com and connect
on Twitter, LinkedIn, Facebook and YouTube.
Advaxis Forward-Looking Statement
Some of the statements included in this press release may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995. The factors that could
cause our actual results to differ materially include: the success
and timing of our clinical trials, including patient accrual; our
ability to release the clinical hold and reduce the impact to our
trials; our ability to obtain and maintain regulatory approval
and/or reimbursement of our product candidates for marketing; our
ability to obtain the appropriate labeling of our products under
any regulatory approval; our plans to develop and commercialize our
products; the successful development and implementation of our
sales and marketing campaigns; the size and growth of the potential
markets for our product candidates and our ability to serve those
markets; our ability to successfully compete in the potential
markets for our product candidates, if commercialized; regulatory
developments in the United States and other countries; the rate and
degree of market acceptance of any of our product candidates; new
products, product candidates or new uses for existing products or
technologies introduced or announced by our competitors and the
timing of these introductions or announcements; market conditions
in the pharmaceutical and biotechnology sectors; our available
cash; the accuracy of our estimates regarding expenses, future
revenues, capital requirements and needs for additional financing;
our ability to obtain additional funding; our ability to obtain and
maintain intellectual property protection for our product
candidates; the success and timing of our preclinical studies
including IND-enabling studies; the timing of our IND submissions,
the ability of our product candidates to successfully perform in
clinical trials; our ability to execute clinical trials; our
ability to maintain collaborations; our ability to initiate pilot
studies and clinical trials, enroll our trials, obtain and maintain
approval of our product candidates; our ability to manufacture and
the performance of third-party manufacturers; the performance of
our clinical research organizations, clinical trial sponsors and
clinical trial investigators; our ability to successfully implement
our strategy; and other risk factors identified from time to time
in our reports filed with the SEC. Any forward-looking
statements set forth in this press release speak only as of the
date of this press release. We do not intend to update any of these
forward-looking statements to reflect events or circumstances that
occur after the date hereof.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180710005293/en/
Investors:LHA Investor RelationsMiriam Weber Miller,
212-838-3777mmiller@lhai.comorAdvaxis, Inc.Ranya Dajani,
609-250-7559dajani@advaxis.com
Ayala Pharmaceuticals (CE) (USOTC:ADXS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Ayala Pharmaceuticals (CE) (USOTC:ADXS)
Historical Stock Chart
From Sep 2023 to Sep 2024